Regulatory Policy Archives - Page 3 of 11

08 Jul 20

Claiming temperature screening products can reliably detect Covid-19 could put people’s health at risk, according to the MHRA's…

MHRA warns manufacturers temperature screening is ‘not a reliable way’ to detect Covid-19

Sommetrics requests emergency use authorization to introduce its aerSleep product for sleep apnea patients at risk of COVID-19

RegulationRegulatory PolicyPatient Care Devices

24 Jun 20

The intent is to reduce transmission of SARS-CoV-2 by those with documented or suspected infection by replacing CPAP…

US Department of Defense to boost Covid-19-related production with $100m initiative

23 Jun 20

The Department of Defense has agreed to fund Covid-19-related production projects following an agreement with the US Development…

Coronavirus (COVID-19) update: FDA issues warning letters to companies inappropriately marketing antibody tests, potentially placing public health at risk

Diagnostic DevicesRegulationRegulatory Policy

18 Jun 20

Agency continues effort to help protect public health from fraudulent products

Coronavirus (COVID-19) Update: FDA publicly shares antibody test performance data from kits as part of validation study

05 Jun 20

These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for…

EU confirms Medical Devices Regulation is postponed until 2021

By Dan Robinson

20 Apr 20

The MDR changes will enforce stricter rules on clinical evaluation processes, safety, classification and performance of medical device…

Have US and UK medical device regulators done all they can to ease ventilator shortages caused by Covid-19?

15 Apr 20

Experts on ventilator regulation in the US and UK weigh in on what relevant bodies have done to…

RegulationApprovals

The regulations non-medical manufacturers may need to overcome to tackle ventilator shortages

27 Mar 20

Manufacturers from industries including automotive want to help the UK ventilator shortage during the Covid-19 crisis - but…

RegulationApprovals

FDA bans ESDs intended for self-injurious or aggressive behaviour

DevicesRegulationRegulatory Policy

05 Mar 20

The agency said that the ESDs are causing unreasonable risk of illness or injury, which cannot be corrected…

Seven serious medical device malfunctions that have led to urgent FDA recalls